FDA Launches New Quality/Compliance Web Content

FDA's Office of Compliance and Biologics Quality (QCBQ) within the Center for Biologics Evaluation and Research (CBER) has launched a web page describing responsibilities such as inspection, surveillance, and compliance to pre- and post- market approval activities.

PPTA News

PPTA Statement on the Inauguration of President Biden +

The Plasma Protein Therapeutics Association (PPTA) and its member companies wish success to President Biden, Vice President Harris, and the dedicated public servants of their Administration as we join them to improve the health of all Americans.
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Yes, you can donate source plasma after getting the COVID vaccine +

Recently, news outlets have suggested that people are not allowed to donate source plasma if they have received either of the two experimental COVID-19 vaccines currently available in the U.S. This is incorrect. Current guidance from the U.S. Food and Drug Administration (FDA) recommends that those who have received one of the available vaccines should not donate convalescent plasma. Healthy and eligible people who have received the COVID-19 vaccine are still encouraged to donate regular source plasma for further manufacture into plasma-derived therapies.
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Treatments for rare diseases at risk, due to the decline of plasma donations +

Representatives of patient advocacy groups, expert physicians, thought leaders, and representatives from the U.S. Food and Drug Administration (FDA) Center for Biologics Evaluation and Research came together on December 9 at a roundtable sponsored by the Plasma Protein Therapeutics Association (PPTA) to discuss the impacts on people with rare diseases if not enough plasma is available to manufacture lifesaving plasma-derived therapies. These therapies are often the only treatments available for people with primary immune deficiencies, bleeding disorders, Alpha-1 Antitrypsin deficiency, hereditary angioedema, and certain neurological conditions.
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Inception Impact Assessment Underlines the Need for Timely Action to Decrease the Reliance on Third Countries for Plasma +

The Plasma Protein Therapeutics Association (PPTA) welcomes the European Commission’s publication of the Inception Impact Assessment (IIA) as a necessary step in the ongoing evaluation of the EU legislation on blood, tissues, and cells (BTC). Rightfully, the assessment underlines the need for timely action to decrease Europe’s reliance on third countries for plasma. We appeal to authorities to urgently take the necessary steps to collect more plasma through plasmapheresis in Europe As highlighted by the European Commission, plasmapheresis is a more efficient collection method compared to the collection of recovered plasma.¹
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FDA Launches New Quality/Compliance Web Content

PPTA Statement on the Inauguration of President Biden +

Yes, you can donate source plasma after getting the COVID vaccine +

Treatments for rare diseases at risk, due to the decline of plasma donations +

Inception Impact Assessment Underlines the Need for Timely Action to Decrease the Reliance on Third Countries for Plasma +

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